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Supplier Quality Engineer II
A career with MilliporeSigma is an ongoing journey of discovery: our 60.300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
At MilliporeSigma, The Supplier Quality Engineer II (SQE) is responsible for ensuring the quality of raw materials used in the production of membrane and pharmaceutical filter products. The SQE will drive major risk reduction initiatives with suppliers to foster supplier continuous quality improvement culture. The desired candidate must be capable of leading supplier audits in accordance with MilliporeSigma and ISO 9001 standards. The SQE must have knowledge of reading and interpreting complex engineering drawings, conducting gage reproducibility and repeatability (R&R) studies, root cause methodology, implementation and monitoring of corrective actions with suppliers, and understanding of validation principles and requirements in a cGMP and GAMP environment.
Essential Job Functions:
- Manage supplier non-conformances to ensure root cause is addressed with timely and effective corrective and preventative actions employing proper root cause analysis methods.
- Conduct supplier audits using a risk-based auditing strategy to identify quality risks and gaps.
- Collaborate with suppliers to drive risk mitigation and ensure effective process controls are in place and are sustained.
- Provide support to incoming inspection and establish disposition plans for quarantined raw material.
- Assist in the initiation and maintenance of Supplier Quality Agreements.
- Provide sound quality and validation input to supplier qualifications (new suppliers, raw material changes, mold tool changes, etc). Ensure all changes follow internal Quality Management Systems. (change control, CAPA, etc).
- Maintain standardized metrics that guide actions and promote continuous improvement (e.g. supplier performance, SCAR responsiveness, etc).
- Provide supplier quality guidance to business partners and lesser experienced engineers.
- Travel to domestic and international supplier locations (20%).
Who You Are:
- Bachelors Degree in a Quality, Technical or Engineering discipline
- 2+ years managing supplier audits and raw material dispositions.
- Experience conducting supplier audits
- Understanding or experience with ISO & FDA regulations (such as 21 CFR 820, 210 & 211).
- Collaborative and motivated team contributor.
- General knowledge of supplier quality in a medical or pharmaceutical manufacturing environment.
- Black Belt or Green Belt
- CQA or CQE
- ISO Auditor
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.